Impact of Gender on the Outcome of Liver Transplantation for Hepatocellular Carcinoma

• Sponsor: Zhejiang University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05643833
• Collaborator: (none)
• Enrollment: 3,769
• Location: 1
• Actual Duration (Months): 21.4
• Patients Per Site Per Month: 175.9

Study Details

Study Description

Brief Summary

This is a large-scale study in China to provide evidence and insights in the role of gender in LT for HCC by analyzing the data of 3769 recipients with HCC registered in the China Liver Transplant Registry.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Liver	Other: no intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 3769 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Impact of Gender on the Outcome of Liver Transplantation for Hepatocellular Carcinoma: A Multicenter Retrospective Study in China
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: May 30, 2022
• Actual Study Completion Date: Oct 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Male recipient	Other: no intervention; no intervention
Female recipient	Other: no intervention; no intervention
Male donor	Other: no intervention; no intervention
Female donor	Other: no intervention; no intervention

Outcome Measures

Primary Outcome Measures

1. Overall survival [January 2015 to December 2020]

   the overall survival of liver transplant recipient with HCC

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

The patients with liver transplants performed from January 2015 to December 2020, whose clinicopathological data were registered in the CLTR.

Exclusion Criteria:

Patients with following features were excluded: with concurrent other malignancies, pathologically-confirmed tumor types other than HCC, such as intrahepatic cholangiocarcinoma (ICC), combined hepatocellular cholangiocarcinoma (cHCC-CC), fibrolamellar hepatocellular carcinoma (FLC) or secondary metastatic tumor; without histological confirmation of HCC for transplantation. The patients who received living donor liver transplantation, split liver transplantation, reduced-size liver transplantation or simultaneous transplantation were also excluded. Next, pediatric patients (<18 years) or senile patients (>65 years) and those patients who died within six months after transplantation were also excluded. Finally, the patients with type-1 and type-2 portal vein tumor thrombus (PVTT), tumor metastasis, having doubtful or contradictory data or missing essential data for analysis, re-transplantation during follow-up time were excluded as well.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

• Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiao Xu, Professor, Zhejiang University
• ClinicalTrials.gov Identifier: NCT05643833
• Other Study ID Numbers: CT2022-ZJU-OBS1
• First Posted: Dec 9, 2022
• Last Update Posted: Dec 9, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma, Hepatocellular; Liver Neoplasms

Study Results

No Results Posted as of Dec 9, 2022